Dynamic weight balancing of flow in kidney failure treatment systems

ABSTRACT

A kidney failure treatment system includes: (i) a dialysate supply; (ii) a weighing device; a control container coupled operably to the weighing device; (iii) a diffusion membrane; (iv) a drain; first and second pumps; (v) a first fluid conduit coupled fluidly to the dialysate supply and the diffusion membrane, the first fluid conduit coupled operably to the first pump; (vi) a second fluid conduit coupled fluidly to the control container and the drain, the second fluid conduit coupled operably to the first pump; and (vii) a third fluid conduit coupled fluidly to the diffusion membrane and the control conduit, the third fluid conduit coupled operably to the second pump.

BACKGROUND

The examples discussed below relate generally to medical fluid delivery.More particularly, the examples disclose systems, methods andapparatuses for the control of fluid flow in kidney failure treatmentsystems.

Due to various causes, a person's renal system can fail. Renal failureproduces several physiological derangements. The balance of water,minerals and the excretion of daily metabolic load is no longer possibleand toxic end products of nitrogen metabolism (urea, creatinine, uricacid, and others) can accumulate in blood and tissue.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life saving.

Hemodialysis and peritoneal dialysis are two types of dialysis therapiesused commonly to treat loss of kidney function. A hemodialysis (“HD”)treatment utilizes the patient's blood to remove waste, toxins andexcess water from the patient. The patient is connected to ahemodialysis machine and the patient's blood is pumped through themachine. Catheters are inserted into the patient's veins and arteries sothat blood can flow to and from the hemodialysis machine. The bloodpasses through a dialyzer of the machine, which removes waste, toxinsand excess water from the blood. The cleaned blood is returned to thepatient. A large amount of dialysate, for example about 120 liters, isconsumed to dialyze the blood during a single hemodialysis therapy.Hemodialysis treatment lasts several hours and is generally performed ina treatment center about three or four times per week.

Another form of kidney failure treatment involving blood ishemofiltration (“HF”), which is an alternative renal replacement therapythat relies on a convective transport of toxins from the patient'sblood. This therapy is accomplished by adding substitution orreplacement fluid to the extracorporeal circuit during treatment(typically ten to ninety liters of such fluid). That substitution fluidand the fluid accumulated by the patient in between treatments isultrafiltered over the course of the HF treatment, providing aconvective transport mechanism that is particularly beneficial inremoving middle and large molecules.

Hemodiafiltration (“HDF”) is another blood treatment modality thatcombines convective and diffusive clearances. HDF uses dialysate to flowthrough a dialyzer, similar to standard hemodialysis, providingdiffusive clearance. In addition, substitution solution is provideddirectly to the extracorporeal circuit, providing convective clearance.

Peritoneal dialysis uses a dialysis solution, also called dialysate,which is infused into a patient's peritoneal cavity via a catheter. Thedialysate contacts the peritoneal membrane of the peritoneal cavity.Waste, toxins and excess water pass from the patient's bloodstream,through the peritoneal membrane and into the dialysate due to diffusionand osmosis, i.e., an osmotic gradient occurs across the membrane. Thespent dialysate is drained from the patient, removing waste, toxins andexcess water from the patient. This cycle is repeated.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis (“APD”), tidal flow APD and continuous flow peritoneal dialysis(“CFPD”). CAPD is a manual dialysis treatment. The patient manuallyconnects an implanted catheter to a drain, allowing spent dialysatefluid to drain from the peritoneal cavity. The patient then connects thecatheter to a bag of fresh dialysate, infusing fresh dialysate throughthe catheter and into the patient. The patient disconnects the catheterfrom the fresh dialysate bag and allows the dialysate to dwell withinthe peritoneal cavity, wherein the transfer of waste, toxins and excesswater takes place. After a dwell period, the patient repeats the manualdialysis procedure, for example, four times per day, each treatmentlasting about an hour. Manual peritoneal dialysis requires a significantamount of time and effort from the patient, leaving ample room forimprovement.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that thedialysis treatment includes drain, fill, and dwell cycles. APD machines,however, perform the cycles automatically, typically while the patientsleeps. APD machines free patients from having to manually perform thetreatment cycles and from having to transport supplies during the day.APD machines connect fluidly to an implanted catheter, to a source orbag of fresh dialysate and to a fluid drain. APD machines pump freshdialysate from a dialysate source, through the catheter, into thepatient's peritoneal cavity, and allow the dialysate to dwell within thecavity, and allow the transfer of waste, toxins and excess water to takeplace. The source can be multiple sterile dialysate solution bags.

APD machines pump spent dialysate from the peritoneal cavity, though thecatheter, to the drain. As with the manual process, several drain, filland dwell cycles occur during APD. A “last fill” occurs at the end ofCAPD and APD, which remains in the peritoneal cavity of the patientuntil the next treatment.

Both CAPD and APD are batch type systems that send spent dialysis fluidto a drain. Tidal flow systems are modified batch systems. With tidalflow, instead of removing all of the fluid from the patient over alonger period of time, a portion of the fluid is removed and replacedafter smaller increments of time.

Continuous flow, or CFPD, systems clean or regenerate spent dialysateinstead of discarding it. The systems pump fluid into and out of thepatient, through a loop. Dialysate flows into the peritoneal cavitythrough one catheter lumen and out another catheter lumen. The fluidexiting the patient passes through a reconstitution device that removeswaste from the dialysate, e.g., via a urea removal column that employsurease to enzymatically convert urea into ammonia. The ammonia is thenremoved from the dialysate by adsorption prior to reintroduction of thedialysate into the peritoneal cavity. Additional sensors are employed tomonitor the removal of ammonia. CFPD systems are typically morecomplicated than batch systems.

In each of the kidney failure treatment systems discussed above, it isimportant to control ulrtrafiltration, which is the process by whichwater (with electrolytes) moves across a membrane, such as a dialyzer orperitoneal membrane. For example, ultrafiltratrion in HD is a result oftransmembrane and osmotic pressure differences between blood anddialysate across a dialyzer membrane. For a given osmotic pressure, thegreater the transmembrane pressure the more rapid the ultrafiltration.

People with kidney failure typically retain water and fluids betweentreatments. That excess fluid needs to be removed during the nexttreatment. It is important to know how much fluid is removed so that thepatient can be returned to their normal weight by the end of therapy. Itis also important in some instances to know accurately the rate at whichultrafiltration is taking place at a given time during therapy.

Different systems have been employed to control ultrafiltration. Onesystem described in U.S. Pat. No. 5,247,434 (“the '534 patent”),assigned to the assignee of the present application, the entire contentsof which are incorporated expressly herein by reference, controlsultrafiltration volumetrically. The patent describes a volumetricallybalanced system that uses first and second chambers of substantiallyequal volume. Each chamber includes two compartments, one termed a“pre-dialyzer” compartment and the other a “post-dialyzer” compartment.Each opposing “pre” and “post” compartment of a chamber is separated bya flexible diaphragm. Solenoid-actuated valves control the filling andemptying of each compartment. In general, each compartment is completelyfilled before its contents are discharged. Also, the “pre” compartmentsare alternately filled and discharged and the “post” compartments arealternately filled and discharged. Filling a “pre” compartment causes adischarge of a corresponding and opposing “post” compartment,respectively. Filling a “post” compartment causes a discharge of acorresponding and opposing “post” compartment.

Since the volumes of opposing “pre” and “post” compartments of the twochambers are equal, the system volumetrically balances the flow ofdialysate to and from the dialyzer. One benefit of this volumetricallycontrolled system is that dialysate flow to the dialyzer can beaccurately measured over a wide range of flow rates.

The volumetric system works well for HD machines placed in centers,which produce dialysate online. In HD, the dialysate is not infused intothe patient and is therefore not considered a drug. The balancingchambers can therefore be located inside the machine and sterilizedbetween treatments. The same balancing chambers are used over and over.

PD infuses dialysate into the patient's peritoneum. Dialysate for PD istherefore considered a drug, so that the dialysate has to meet sterilityrequirements for a drug. Anything that comes in contact with thedialysate must also be sterilized and discarded after use. For PD then,at least a component of the balancing chambers would have to besterilized and disposable, making balancing chambers for PD lessattractive from a cost standpoint, compared for example to simple tubingused with peristaltic pumps.

Problems exist with prior fluid control systems employing scales tomeasure the weight of fluid delivered to and taken from the patient. Forexample, previous systems employing scales have had to be robust enoughto accommodate the total size and weight of the dialysate used duringtreatment. The load cells of systems have an associated error, which isbased on a percentage of the total weight of fluid. As the total weightof the fluid increases, the error increases correspondingly and beginsto compromise the accuracy of the system.

Also, because all the bags have to be weighed, a relatively robustmechanical base hanging system has to be provided to handle theassociated stresses. Further, the size of the weighing system makes itmore prone to interferences from bumps or hits for example. The size ofthe weighing system can also make storage of the multiple bagsdifficult, for example, providing a container or support system capableof isolating the weighing system from mechanical interferences andprotecting the load cell.

Moreover, multiple supply bags can be complex and difficult for thepatient to attach to the weighing system. For example, the multiple bagsmay have to be lifted to an inconvenient height. Also, in priorgravimetric systems, spent dialysate has to be collected, requiring theoperator to carry heavy, full bags of fluid twice, once for setup andagain after treatment. A need therefore exists for a simplified andrelatively inexpensive fluid control system for kidney failuretreatments, which is accurate and easy to maintain.

SUMMARY

The examples described herein disclose dynamic weight or gravimetricbalancing medical fluid flow systems and methods applicable for exampleto: hemodialysis (“HD”), hemofiltration (“HF”), hemodiafiltration(“HDF”), peritoneal dialysis ((“PD”), including continuous ambulatoryperitoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”),tidal flow APD and continuous flow peritoneal dialysis (“CFPD”)modalities). The systems may also be used in any type of continuousrenal replacement therapy (“CRRT”). The examples below include adiffusion membrane or filter, such as a dialyzer, e.g., for HD or HDF, ahemofiliter, e.g., for HF or the patient's peritoneum, e.g., for PD.Moreover, each of the systems described herein may be used in clinicalor home settings. For example, the systems may be employed in anin-center HD machine, which runs virtually continuously throughout theday. Alternatively, the systems may be used in a home PD machine, whichis typically run at night while the patient is sleeping.

The examples below include a dialysate (replacement fluid) supply, whichfor convenience is shown as a single bag of the fluid. Alternatively,multiple bags of dialysate supply are ganged together and used one afteranother. Further alternatively, each of the systems shown below can beused with an online source, such as one or more concentrate pumpconfigured to combine one or more concentrate with water to formdialysate online. Online sources are used commonly with HD systems forexample.

In one example, a system and method are provided in which a controlcontainer is coupled operably to a weighing device, which communicateswith a control device. Two pumps are provided, which can be peristalticpumps. The first pump drives segments of two different tubes. One tubesegment delivers fresh dialysate to an inlet of one of theabove-described filters. The other tube segment pulls fluid from thecontrol bag to a drain. The second pump segment pumps fluid from thefilter into the control bag. In theory, the fluid volume/rate pumpedthrough the two tubes operable with the same pump head is the same,making the fresh dialysate pumped to the inlet of the filter equal orsubstantially equal to the spent dialysate pumped from the control bag.

Any difference in weight gained or lost within the control bag thereforecorresponds to a net ultrafiltration volume removed from the patient ora net amount of fresh dialysate supplied to the patient, respectively.This system enables both the total amount of fluid removed or added tothe patient plus the rate of which such fluid is removed or added to thepatient to be known. Accordingly, the system provides a relativelynoncomplex and accurate way to monitor a kidney failure therapy, such asHD, and to control the ultrafiltration rate, such as according to a UFprofile.

It may be determined that the actual difference in flow through the twopump segments operable with the first pump head is different enough,such that an error detection and/or correction apparatus and method isneeded. One such embodiment for detecting an error includes a bypassline connected between the fresh dialysate line (extending from thefresh dialysate supply to the inlet of the filter) to the spentdialysate return line, which operates with the second pump and leads tothe control container. The system is valved such that at a desired pointand time, the filter is bypassed. That is, fresh dialysate that wouldnormally flow to the filter is sent instead to the control bag. Thesecond pump is not operated, so that no new ultrafiltration is pulledfrom the filter to the control bag.

In theory, the weight of liquid in the control container should notchange over time because the first pump is theoretically pushing in andpulling dialysate to and from the control bag at the same rate. Adetected increase or decrease in the weight of fluid within the controlcontainer corresponds to a corresponding differential between the fluidpumped through the two tubes operating with the first pump. This erroris determined and compensated for during therapy.

One apparatus and method for correcting a detected flow differentialthrough the two tubes includes placing a closed-loop around each of theportions of the tubes operable with the first pump. A pressure reliefvalve is placed in each of these closed-looped lines. A valve is locateddownstream from each of the closed-loop lines. Thus if one tube ispumping more than the second tube, the valve corresponding to the higherflow tube can be closed, causing pressure in that closed-loop to buildand correspondingly opening the relief valve. This enables the dialysateto idle around the closed-loop for a portion of time until the flowdifferential is corrected.

A further method of compensation also has the advantage of zeroing outany flow differential without the need to detect the differentialbeforehand. Here, line swapping flow paths are added upstream anddownstream of the first path in combination with a valving arrangementsthat enable the flow of fresh and spent dialysate to switch back andforth in equal increments between the different tube segments operatingwith the first pump. Here, if any differential does exist through thetwo segments, the overall corresponding amount of fluid is made to bethe same by switching the flows back and forth to cancel out the error.This is done without necessarily detecting the error.

In another embodiment, a third pump is added. Here the first pump drivesonly the fresh dialysate from the dialysate supply to the filter ordiffusion membrane. The second pump as before pumps spent dialysate fromthe filter to the control container. The third pump is configured topull spent dialysate from the control container and pump such spentdialysate to drain. The third pump is run to match flow and volume withthe first pump, such that the amount of fluid delivered to the filter isthe same amount of fluid removed from the control container. Here again,any increase or decrease in weight sensed by the weighing deviceoccurring in the control bag corresponds to a net removal or addition offluid into the patient. And a sensed rate of change corresponds to therate of fluid removed or delivered to the patient.

In a further alternative embodiment, the control container is dividedinto fresh and spent portions. Additional fluid lines and valves areadded, such that in one valve state the first or dual segment pump pumpsfresh dialysate into and out of the fresh portion of the controlcontainer simultaneously. The second pump pumps fluid from the filter toa drain. This first valve state provides a calibration mode, which: (i)assures that the flow through the dual segments operable with the firstpump is matched or (ii) enables a flow differential to be determined andcorrected. In this first valve state, pump 20 b is run at the same speedas pump one, enabling clearance but not ultrafiltration to occur. Nocorresponding ultrafiltration from the patient should take place becausethe corresponding increase in weight is not delivered to the controlcontainer.

In a second valve state, the dual segment first pump pumps freshdialysate into the filter and at the same time removes spent dialysatefrom the spent portion of the control container and delivers same todrain. The second pump pumps fluid into the spent portion of the controlcontainer. This second valve state operates much like the embodimentsdescribed above, wherein flow to the filter and from the controlcontainer is matched theoretically, such that any increase or decreasein weight due to a mismatch in spent fluid pumped by the second pumpinto the spent portion of the control container corresponds to a netfluid loss or gain by the patient.

In a further alternative embodiment, the dual chamber control containeris operated with three pumps. Here, the first pump drives freshdialysate to the filter. The second pump pulls spent fluid from thefilter. The third pump operates a loop that can either deliver freshfluid to the control bag or remove spent fluid from the control bag. Thedialysate pathways are valved such that: (i) the first pump canalternatively deliver fresh dialysate from the fresh portion of thecontrol container to the filter; and (ii) such that the second pump canalternatively deliver spent dialysate from the filter to the controlcontainer.

In a first valve state, the first pump is configured to deliver freshdialysate from the control container to the filter. The second pump isconfigured to drive spent fluid directly from the filter to drain. Thethird pump is configured to deliver fresh dialysate from the dialysatesupply to the fresh portion of the control container. Here, the secondpump is set to run at the same speed as the third pump, such that a gainin weight in the fresh compartment of the control container correspondsto an amount of ultrafiltrate that has been removed from the patient.Alternatively, a net loss in weight of fluid in the fresh portion of thecontrol container corresponds to fluid having been added to filter andthus the patient.

In a second valve state, the first pump is configured to drive freshdialysate directly from the supply to the filter. The second pump isconfigured to pump spent dialysate from the filter to the spent portionof the control container. The third pump is configured to pull spentdialysate from the spent portion of the control container and pump suchspent dialysate to drain. Here, the first pump speed is set to equal thethird pump speed. Thus any increase in weight in the control containercorresponds to a like amount of ultrafiltrate being removed from thefilter and the patient. On the other hand, any decrease in weight offluid in the spent portion of the control container corresponds to a netamount of fluid being delivered to the dialyzer or the patient.

Various embodiments for the weighing device/control containerconfiguration are also disclosed. In one embodiment, the weighing deviceincludes a hook or similar mechanism from which the control container ishung. In another embodiment, the weighing device includes a platformonto which the control container is directly placed. Here, the controlcontainer is configured to be structurally rigid enough to supportitself as well as the weight of dialysate pumped into the container. Ina further alternative embodiment, a bin is placed on, attached to orformed integrally with the platform of the weighing device. The controlcontainer is placed in and supported by the bin. Here, the controlcontainer can be of a flexible material that can deform when placed inthe bin.

In an embodiment, pressure regulators and/or pressure transducers areplaced at the inlet of the dual segment or single segment pumpingperistaltic pumps to help ensure that different peristaltic pumps pumpthe same flow, at equal speeds, when desired. Such regulators andtransducers also help to ensure that the same pump operating dual pumpsegments pumps the same flow at equal speeds. The pressure regulatorsand/or transducers are alternatively placed in any combination eitherupstream or downstream of any of the peristaltic pumps in any of theembodiments described herein.

It is therefore an advantage of the examples discussed herein to providea fluid control system for kidney failure treatments, which does nothave to maintain constant the total volume of dialysate delivered andultrafiltrate removed over an entire therapy.

It is another advantage of the examples discussed herein to provide aweight balancing fluid control system, which does not requirecomplicated bag managing devices.

It is a further advantage of the examples discussed herein to provide afluid control system for kidney failure treatments having improvedergonomics, such as one in which only a single bag has to be installedas opposed to multiple bags, easing removal and disposition of thesingle bag after therapy.

It is yet another advantage of the examples discussed herein to providea weight balancing fluid control system having improved resolution.

It is yet a further advantage of the examples discussed herein toprovide a weight balancing fluid control system that allows for spentdialysate to be discarded during therapy.

It is still another advantage of the examples discussed herein toprovide a weight balancing fluid control system that minimizespost-treatment clean up.

It is still a further advantage of the examples discussed herein toprovide a weight balancing fluid control system that is capable of usingonly a single weighing device.

Additional features and advantages are described herein, and will beapparent from, the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic illustration of one example of a kidney failuretherapy weight balancing fluid control system in a first valve state.

FIG. 2 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 1 in a second valve state.

FIGS. 3A and 3B are elevation views of two embodiments for dual tubingperistaltic pumps used with the systems described herein.

FIG. 4 is a schematic illustration of another example of a kidneyfailure therapy weight balancing fluid control system in a first valvestate.

FIG. 5 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 4 in a second valve state.

FIGS. 6 to 8 are schematic illustrations of a closed loop flowdifferentiation compensation apparatus and method in three differentvalve states, respectively.

FIGS. 9 and 10 are schematic illustrations of a path sharing flowdifferentiation compensation apparatus and method in two different valvestates, respectively.

FIG. 11 is a schematic illustration of a further example of a kidneyfailure therapy weight balancing fluid control system, which employs athird pump.

FIG. 12 is a schematic illustration of yet another example of a kidneyfailure therapy weight balancing fluid control system in a first valvestate, which has a control container with separated fresh and spentportions.

FIG. 13 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 12 in the first valve state withclosed-off sections of the flow path eliminated for clarity.

FIG. 14 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 12 in a second valve state.

FIG. 15 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 14 in the second valve state withclosed-off sections of the flow path eliminated for clarity.

FIG. 16 is a schematic illustration of yet a further example of a kidneyfailure therapy weight balancing fluid control system in a first valvestate, which has a third pump and a control container with separatedfresh and spent portions.

FIG. 17 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 16 in the first valve state withclosed-off sections of the flow path eliminated for clarity.

FIG. 18 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 16 in a second valve state.

FIG. 19 is a schematic illustration of the kidney failure therapy weightbalancing fluid control system of FIG. 18 in the second valve state withclosed-off sections of the flow path eliminated for clarity.

FIGS. 20 to 22 are schematic illustrations of different embodiments forweighing device/control container combinations used with the systemsdescribed herein.

FIGS. 23 and 24 are schematic illustrations of pressure regulationapparatuses and methods.

DETAILED DESCRIPTION

The examples described herein are applicable to any medical fluidtherapy system requiring the delivery to and/or removal of fluid from apatient to be monitored and/or controlled accurately. The systems areparticularly well suited for the control of kidney failure therapies,such as all forms of hemodialysis (“HD”), hemofiltration (“HF”),hemodiafiltration (“HDF”), peritoneal dialysis (“PD,” includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis (“APD”), tidal flow APD and continuous flow peritoneal dialysis(“CFPD”) modalities). The systems may also be used in any type ofcontinuous renal replacement therapy (“CRRT”).

The examples below include a diffusion membrane or filter, such as adialyzer, e.g., for HD or HDF, a hemofiliter, e.g., for HF or aperitoneum, e.g., for PD. The drawings each show a to-filter andfrom-filter line, which is the case for HD. HDF includes an additionalone or more fresh replacement fluid line (not shown) leading directly tothe extracorporeal circuit, either upstream or downstream (or both) fromthe dialyzer. The additional one or more fresh replacement fluid linecan be teed off of the to-filter line, for example.

Instead of the to-filter line, HF runs the same line to theextracorporeal circuit, either upstream or downstream (or both) from thehemofilter. HF uses the from-filter line as shown in the drawings.

In PD, the type of modality dictates the tubing configuration. CAPD andAPD are batch-type systems, which typically require only a single lineto the patient. Dialysate in CAPD and APD is typically delivered to thepatient, allowed to dwell for a period, and then pumped from the patientand discarded to drain. Those cycles are then repeated a number oftimes. The to- and from-patient lines are teed together and valvedappropriately, for example, so that dialysate can be delivered andremoved at different times via the same single line and connection toand from the patient. CFPD typically uses a dual lumen catheter and thusrequires the to-patient and from-patient (to-filter and from-filter)lines shown in the drawings.

Moreover, each of the systems described herein may be used in clinicalor home settings. For example, the systems may be employed in anin-center HD machine, which runs virtually continuously throughout theday. Alternatively, the systems may be used in a home PD machine, whichis typically run at night while the patient is sleeping.

The examples below include a dialysate (replacement fluid) supply, whichfor convenience is shown as a single bag of the fluid. Alternatively,multiple bags of dialysate supply are ganged together and used one afteranother. In such a case, the emptied supply bags can serve as drain orspent fluid bags. Further alternatively, each of the systems shown belowcan be used with an online source, such as one or more concentrate pumpconfigured to combine one or more concentrate with water to formdialysate online. Online sources are used commonly with HD systems forexample.

Although not illustrated, each of the systems shown and described hereincan operate with an online or batch heater that heats the dialysate orreplacement fluid to a desired temperature. The heater can be locatedupstream or downstream of the fresh supply pump for example. One or moreair removal detector and device (e.g., air trap) is also provided foreach of the systems in an embodiment. The air trap is in many instanceslocated at or near the heater to capture air egression from the solutiondue to heating.

The flow schematics shown herein show the dialysate or replacement fluidportion of the kidney failure therapy device. HD, HF and HDF machinesalso include blood pumping systems, which are known in the art and neednot be shown here. HD, HF and HDF also include dialysate proportioningsystems, mentioned above, which are also known and need not be describedhere. The '534 patent, incorporated herein by reference, describes aproportioning system for example.

The dynamic weighing systems described herein can be used for a numberof purposes. One purpose is to control ultrafiltration volume. Thesystems provide an accurate and relatively non-complex way ofcontrolling and knowing how much ultrafiltrate has been removed from thepatient. The systems ensure that the necessary amount of fluid isremoved from the patient by the end of treatment.

Additionally, the systems can be used to control ultrafiltration (“UF”)rate. The '534 patent, incorporated herein by reference, describes UFprofiling, which enables the rate at which fluid is removed from thepatient to vary desirably over the course of treatment. Because theweighing systems are dynamic, they allow information to be determined ona real time basis. For example, the systems can determine that onehundred milliliters (“ml”) of fluid have been removed from the patientover the past minute, yielding a UF rate of 100 ml/min. That actual ratecan then be compared to a desired rate set according to a prescribed UFprofile, so that the pumps can be adjusted if needed to make the actualrate equal the desired rate.

The systems described herein are also provided in an enclosure (notillustrated for convenience) The enclosures will vary depending on thetype of treatment, whether the treatment is in-center or a hometreatment, and whether the dialysate/replacement fluid supply is abatch-type (e.g., bagged) or online. The in-center, online enclosurestend to be bigger and more robust due to the additional dialysateproducing equipment and the frequency of use of such machines. Hometherapy enclosures are desirably smaller and built so that the machinescan be moved about ones home or for travel.

Referring now to the drawings and the particular to FIGS. 1, 2, 3A to3B, one example of a dynamic weight or gravimetric balancing system isillustrated by the system 10. System 10 is shown in a first valve statein FIG. 1 and in a second valve state in FIG. 2. As shown in FIGS. 1 and2 (and as maintained throughout this application, as shown in the keybelow filter 18), valves that are currently open are shown unbolded oruncolored, while valves that are currently closed are shown bolded orcolored. System 10 includes a dialysate or replacement fluid supply 12,which can be any of the types described above. As used herein, the term“dialysate” is meant to cover any of the batch or online fluids preparedin any of the treatments discussed above, including dialysate four HDand HDF. The term also encompasses any dialysate made for any batch orcontinues type of PD system (dialysate for PD includes glucose in a highconcentration). Further, the term dialysate covers replacement fluidused in HF and HDF.

System 10 also includes a drain bag 14, which can be a single drain bag,a plurality of drain bags, a large drain container. System 10 alsoincludes a house drain 24, which can any type of a toilet or any type ofdrain installed in a hospital, home or clinic. A fresh dialysate line 16is connected fluidly to dialysate supply 12 and the inlet of filter 18.Filter or diffusion membrane 18 can be any of the types discussed above.Dialysate supply line 16 is also coupled operably to a first pump 20 a,which in an embodiment is a peristaltic pump. Peristaltic pump 20 a isdiscussed in more detail below in connection with FIGS. 3A and 3B.

A drain line 22 is connected fluidly between drain bag 14 and//or housedrain 24. A first spent dialysate line 26 is connected fluidly to acontrol container 30 and drain line 22. First spent dialysate line 26 isalso coupled operably (along with fresh supply line 16) to firstperistaltic pump 20 a. A second spent dialysate line 28 is connectedfluidly to the outlet of filter or diffusion membrane 18 and control bag30. Second spent dialysate line 28 is coupled operably to peristalticpump 20 b. First and second valves 32 and 34 as illustrated areconfigured to selectably occlude drain line 22 at positions located oneither side of the fluid connection between first spent dialysate line26 and drain line 22.

Control bag 30 is coupled operably to a weighing device or scale 50.Various combinations of control bag 30 and weighing device 50 are shownand described below in connection with FIGS. 20 to 22. Any of theembodiments shown below in connection with FIGS. 20 to 22 is applicableto any of the systems described herein, including system 10.

Weighing device 50 sends an electronic signal 52, such as a zero to fiveVDC or four to twenty mA signal (analog in one embodiment) to a controldevice 100. Control device 100 can be any suitable type of logicimplementor, such as one containing any one or more of a processor, arandom access memory (“RAM”), a read-only memory (“ROM”) or anapplication specific integrated circuit (“ASIC”). In an embodiment,control device 100 is a subcontroller or delegate printed circuit board(“PCB”), which communicates with one or more supervisory, master controlor motherboard. For example, control device 100 can be a printed circuitboard, which controls certain related functions, such as UF control,dialysate proportioning, dialysate pressure control, dialysatetemperature control, and other related dialysate parameters. The use ofsubcontrollers in combination with one or more motherboard is discussedin the '534 patent, incorporated herein by reference.

Besides signal 52, control device 100 receives and generates additionalsignals, which may be of any suitable type including those listed abovefor signal 52. Any of the signals generated and/or received by controldevice 100 may be analog or digital. For example, control device 100also receives pressure signals 54 a and 54 b from pressure transducers56 a and 56 b, respectively. Control device 100 further generates andsends signals 58 a and 58 b to pumps 20 a and 20 b. In an embodiment,signals 58 a and 58 b are variable current signals that control thespeed of pumps 20 a and 20 b. Signals 58 a and 58 b are alternativelypulsed voltage or transistor-transistor logic (“TTL”) type signals thatare sent to a local controller at pumps 20 a and 20 b. The local pumpcontrollers convert the digitized signals into motor currents thatcontrol the speed of pumps 20 a and 20 b.

Control device 100 also sends signals 62 a and 62 b to valves 32 and 34.Valves 32 and 34 in an embodiment are normally open or normally closedsolenoid valves. Signals 62 and 62 b electronically and automaticallycontrol whether any particular valve is open or closed at any particulartime. Control device 100 in an embodiment maintains software thatsequences the valves, such as valves 32 and 34 at appropriate times.Control device 100 also maintains software that compares the value atany given time for signal 52 from weighing device 50 with a preset ordesired value, which determines whether enough fluid is maintainedwithin control bag 30 or whether UF rate is proper, and thus whether tospeed up or slow down one or both of pumps 20 a and 20 b.

As illustrated, peristaltic pump 20 a has a common head that drivesfresh dialysate from supply 12, through fresh supply line 16 to theinput of filter 18, while at the same time pulling the spent dialysatefrom control bag 30, through the first spent dialysate line 26, to drainline 22, and thereafter to either drain bag 14 or house drain 24.

Referring additionally to FIGS. 3A and 3B, which show enlarged views oftwo embodiments for peristaltic pump 20 a driving two pumping segmentsof tubes 16 and 26, matching the flow through each segment 16 and 26theoretically. In each case, peristaltic pump 20 a includes a race 64and a roller spindle 66 having three drive rollers 68 a to 68 c, forexample, in FIG. 3A, and two drive rollers 68 a and 68 b in FIG. 3B.Other peristaltic pump configurations (e.g., more or less rollers,cylindrical versus tapered rollers, linear rollers) may be employedalternatively. Peristaltic pumps, such as pump 20 a, are used typicallyto pump clean or sterile fluids, such as dialysate or replacement fluid,because the pump hardware does not contact and thus contaminate thefluid. The only part of the pump in contact with thedialysate/replacement fluid is the interior of the tube segments oflines 16 and 26 contacting race 64, which are cleaned and sterilizedbefore therapy. Also, because peristaltic pumps include no moving partsin contact with the dialysate/replacement fluid, the pumps arerelatively inexpensive. Peristaltic pumps also lack the valves, sealsand glands used in other types of pumps, which makes pump 20 a forexample comparatively inexpensive and easy to maintain.

The primary difference in pump 20 a of FIG. 3A is that in FIG. 3A, therollers pinch tubes 16 and 26 together against race 64. Here, tube 16 isfilled between tube 26 and race 64. In pump 20 a of FIG. 3B, on theother hand, tube 16 lies in front of tube 26. Here, length of rollers 68a and 68 b extends far enough so that they can contact both tubes 16 and26, which are placed directly adjacent to each other in one embodiment.

In the operation of system 10 of FIGS. 1 and 2, control container 30contains a fixed volume of dialysate at the start of treatment. Asdiscussed above, weighing device 50 weighs control container 30constantly and sends a constant signal 52 representing the weight ofdialysate within control bag 30 to control device 100. Pump 20 b pumpsspent dialysate from filter or diffusion membrane 18 into controlcontainer 30. Simultaneously, pump 20 a drives fresh fluid from supply12 into filter 18. Pump 20 a also simultaneously pumps spent fluid fromcontrol container 30 to either drain bag 14 or house drain 24.

In an embodiment, the pressure of dialysate in lines 16 and 26 upstreamor at the inlet side of pump 20 a is at or close to atmospheric.Differences in pressure of dialysate in lines 16 and 26 are measured orread by pressure transducers 56 a and 56 b which send correspondingsignals 54 a and 54 b to control device 100 (see also FIGS. 23 and 24).Pressure differences of an elevated magnitude may indicate a mechanicalerror, for example, causing flow through lines 16 and 26 to not bematched.

Assuming pump 20 a pumps the same flow through lines 16 and 26, thevolume of fresh dialysate sent to filter 18 is or should be at leastsubstantially equal to the volume of spent fluid that is removed fromcontrol container 30. If no ultrafiltration is desired, for example ifit is desired to run a therapy or a portion of therapy in which fluid isnot to be removed from the patient, then pump 20 b is adjusted so thatthe weight of spent dialysate maintained within control container 30 isconstant or unchanging. That is, the amount or rate of fluid beingdelivered to filter 18 is the same as the amount or rate of fluid thatis being removed from filter 18, which is the same as the amount orweight of fluid that is being pumped to drain 14 or 24.

If ultrafiltration is desired, that is if it is desired to run system 10to produce a resulting net removal of fluid from the patient, thencontrol device 100 adjusts the speed of pump 20 b such that spentdialysate pulled from filter 18 accumulates within control container 30at a predetermined rate. The faster pump 20 b is run with respect to thespeed of pump 20 a, the faster the spent dialysate fills controlcontainer 30, and thus the faster that ultra filtrate is removed fromthe patient.

System 10 provides a negative feedback loop, with control container 30measuring the error or imbalance between the flow of fresh dialysate andspent dialysate. Because system 10 balances the flow of fresh and spentdialysate via the measurement of error, the need to preserve or maintainthe total volume of each of these fluid flows is not necessary. Thisarrangement allows for the continuous disposal of spent dialysate todrain 14 or 24 (via the configuration of valves 32 or 34). In oldersystems, spent fluid would have to be accumulated, e.g., in drain bag14, for the purpose of comparing (e.g., for controlling UF) the amountof spent dialysate in drain bag 14 with the amount of fresh dialysatedelivered from supply 12. In system 10, such overall comparison is notnecessary. This eliminates problems inherent in such weighing systems,such as inherent inaccuracy, misplacement or movement of bags duringtherapy, and other problems listed above.

It should be appreciated that control device 100 of system 10 canreadily and accurately calculate the total volume of fluid removed fromthe patient by dividing the weight of spent dialysate gained withincontrol container 30 over the course of treatment by the density ofspent dialysate. The amount or volume of fluid delivered to filter 18 orto drain 14 or 24, which is less important to monitor than the amount ofUF removed, can be at least approximated by multiplying the number ofrevolutions made by the head of pump 20 a by an average volume of fluidpumped per revolution. If needed, system 10 can employ flow accumulatingdevices that monitor the flow and/or amount of fluid flowing throughlines 16 and 22 and send a signal to control device 100 for readout andtherapy record keeping purposes.

The matched rate-based system 10 lends itself readily to theabove-described UF profiling. Keeping the rate of pump 20 a constant,control device 100 of system 10 can vary the speed of pump 20 baccording to a stored UF profile to vary the rate of ultrafiltrationdesirably over time and, for example, remove more UF over the first halfof therapy than over the second half. In this manner, system 10 cancontrol the speed of pumps 20 a and 20 b according to any suitablydesirable UF profile.

The assumption of equal flow through fresh supply line 16 and firstspent dialysate line 26 via the pumping of pump 20 a is not necessarilyor absolutely correct. The manufacturing tolerances of the tubes and/orinconsistencies in the race 64 of pump 20 a (as seen in FIG. 3) couldcause flow through one of the lines 16 or 26 to be greater or less thanflow through the other line. Described below are various apparatuses andmethods for detecting and/or correcting for differences between the flowthrough the segments of lines 16 and 26 operating with pump 20 a. Afirst apparatus and method is discussed in connection with system 110 ofFIGS. 4 and 5.

Referring now to FIGS. 4 and 5, alternative system 110 is illustrated.System 110 includes many of the same components described above forsystem 10, such as supply 12, drain bag 14, fresh supply line 16, filter18, peristaltic pumps 20 a and 20 b, drain line 22, house drain 24,first spent dialysate line 26, second spent dialysate 28, control bag30, solenoid valves 32 and 34, weighing device 50, signal 52 fromweighing device 50 to control device 100, signals 54 a and 54 b fromrespective pressure transducers 56 a and 56 b to control device 100,pump speed output signals 58 a and 58 b to pumps 20 a and 20 b, andsolenoid output signals 62 a to 62 n to control solenoid valves, such asvalves 32 and 34. Segments of lines 16 and 26 are again drivensimultaneously by pump 20 a. A segment of line 28 is again driven bypump 20 b.

A pressure regulator 72 is placed in supply line 16, downstream frompump 20 a. Pressure regulator 72 sets a pressure upstream of regulator72, between the regulator and pump 20 a. The pushback by regulator 72helps the output of pump 20 a to be more steady, e.g., reduced pressureand/or flow fluctuations. The regulation of upstream pressure tends tomake the output through the segment of line 16 operating with pump 20 abe more closely matched to the pressure and volumetric characteristicsof segment 26 operating with pump 20 a. The pumping regime is therebymore volumetrically accurate. Although not illustrated, a regulator 72can be additionally or alternatively positioned in line 26 downstreamfrom pump 20 a. Further, any of the pumps 20 a, 20 b, 20 c, etc.,described herein can operate with a downstream regulator 72.

The primary difference between system 110 and system 10 is that a bypassline 70 is added to enable fluid communication between fresh supply line16 and second spent dialysate line 28. A third valve 36 is positioned toopen or occlude bypass line 70. A fourth valve 38 is positioned to openor occlude second spent dialysate line 28 downstream of pump 20 b. Afifth valve 40 is positioned to open or occlude fresh supply line 16, ata point prior to the connection of line 16 and filter 18.

System 110 when valve 36 is closed and valve 38 is open as seen in FIG.4 behaves the same as system 10 described previously. That is, pump 20 amatches fresh dialysate pumped to filter 18 with spent dialysate pulledfrom control container 30. Control device 100 controls the rate ofultrafiltration, if any, by varying the speed of pump 20 b as needed. Itshould be noted that in this valve state, valve 40 is opened to enablefresh dialysate to flow from supply 12 to filter or diffusion membrane18.

When the state of the valves in FIG. 4 is reversed, as shown in FIG. 5,system 110 closes valves 38 and 40 and opens valve 36 to stop dialysateflow to and from filter 18. In this state, filter 18 is bypassed. Pump20 b is stopped. Pump 20 a pumps dialysate to container 30 from supply12 and dialysate from container 30 via line 26 simultaneously. Weighingdevice 50 in combination with control device 100 attempt to detect anygain or loss of fluid within control container 30. If the flow throughfresh supply line 16 is greater than the flow through first spentdialysate line 26, then fluid accumulates in control container 30. Acorresponding signal 52 is detected by control device 100, which adjustspump 20 b accordingly when the valves are reverse to the therapy stateof FIG. 4. Conversely if flow through first spent dialysate line 26 isgreater than the flow through fresh supply line 16, then the amount offluid in control container 30 will decrease over time, causing acorresponding drop in weight would be measured and delivered to controldevice 100. Diagnostic valve state of FIG. 5 it should be appreciateddetects differences in flow through the segments of lines 16 and 26communicating with pump 20 a.

In either case, the difference in flow through the lines 16 and 26 canbe determined and compensated for by controlling the speed of pump 20 bonce therapy is resumed. For example, if fresh dialysate is being pumpedto filter 18 at a rate X faster than fluid is being pulled from controlcontainer 30, then the speed of pump 20 b can be increased by rate X toproduce the desired rate of UF removal. On the other hand, if fluid isbeing pulled from control container 30 at a rate Y faster then fluid isbeing delivered to filter 18, then the speed of pump 20 b can be reducedby rate Y to achieve the desired rate of UF removal.

In an embodiment, control device 100 of system 110 is configured toperiodically switch from the normal operating valve state of FIG. 4 tothe diagnostic bypass valve state of FIG. 5. Each time, control device100 recalculates the delta rate of dialysate that pump 20 a is pumpingthrough lines 16 and 26 and adjusts pump 20 b accordingly.

System 110 can also detect a potentially catastrophic difference betweenthe rates of fluids pumped through lines 16 and 26 by pump 20 a. Forexample, if the error between the two rates is too large, controlcontainer 30 may not have enough capacity to compensate for the errorover the course of treatment. For example, if the rate of fluid beingremoved from controlled container 30 is too slow, container 30 mayoverflow by the end of therapy. System 110 is configured to detect sucha condition, send an error message to the patient or operator, andpotentially shut down the pumping of the system.

An apparatus and method for compensating a difference in flow betweenfresh supply line 16 and first spent dialysate line 26 via the pumpingof single pump 20 a is illustrated in connection with FIGS. 6 to 8.FIGS. 6 to 8 show a portion of an overall system, which can be anysuitable overall system described herein, such as system 10.

In the system employing the arrangement of FIGS. 6 to 8, valves 40 and42 are added to lines 16 and 26, respectively, downstream of pump 20 a.Closed loop producing or loop-closing lines 74 and 76 are placed influid communication with lines 16 and 26, respectively, producing ineach line a closed fluid loop around pump 20 a. Each closed loopproducing line 74 and 76 has a corresponding relief valve 78 a and 78 b.The configuration in FIGS. 6 to 8 enables one of the lines 16 or 26 todesirably stop driving fluid to its therapeutic destination. FIG. 6shows the normal operating state when pump 20 a pumps fluid through bothlines 16 and 26.

Closing valve 40, as seen in FIG. 7, causes the pressure in line 16upstream of valve 40 to increase. Eventually, when the pressure reachesa certain point, relief valve 78 a opens causing pump 20 a to pump freshdialysate back through closed loop line 74 to the upstream side of pump20 a. This closed loop stops the flow of fresh dialysate to filter 18.In the meantime, pump 20 a continues to pump spent dialysate fromcontrol container 30, through line 26, and through open valve 42 todrain 14 or 24. This state is shown in FIG. 7.

FIG. 8 shows the reversed state with valve 42 closed and valve 40 open.Here, pressure builds in the closed loop line 76 to a point at whichpressure relief valve 78 b opens, enabling fluid to flow through closedloop line 76, creating a closed loop around pump 20 a in line 26, andstopping dialysate flow from control container 30 to drain bag 18. Atthe same time, pump 20 a pumps fluid from supply 12 to filter 18.

The apparatus and method of FIGS. 6 to 8 is a flow compensationapparatus, which can be used in combination with any type of errordetecting scheme to compensate for a detected error. For example, theapparatus and method of FIGS. 6 to 8 can be used for compensation insystem 110 of FIGS. 4 and 5 instead of adjusting the rate of pump 20 b.Alternatively, the compensation apparatus and method of FIGS. 6 to 8could be used with any error determining scheme for detectingdifferences in flow in lines 16 and 26 during a calibration mode. Duringtherapy, control device 100 closes either valve 40 or 42 temporarily foras long or as many times as needed to maintain the weight in controlcontainer 30 constant or to have the weight increase according to adesired UF rate or UF profile.

Referring now to FIGS. 9 and 10, another apparatus and method forcompensating between a difference of flow in lines 16 and 26 isillustrated. FIGS. 9 and 10 again show a portion of an overall system,which can be any suitable overall system described herein, such assystem 10. As will be appreciated, the compensation apparatus and methodof FIGS. 9 and 10 is desirable in one aspect because it automaticallycompensates for flow differences caused by tubing and pump raceinconsistencies without having to detect such differences. The apparatusand method of FIGS. 9 and 10 can also be incorporated as desired intothe overall systems described herein

The apparatus and method of FIGS. 9 and 10 includes a pair of lineswapping flow paths 48 a and 48 b located downstream of pump 20 a. Apair of line swapping flow paths 88 a and 88 b are also providedupstream of pump 20 a. Each of the line swapping flow paths establishesa valved fluid communication between fresh supply line 16 and firstspent dialysate line 26.

As seen in FIGS. 9 and 10, line swapping flow path 48 a operates withoccluding solenoid 44, while flow path 48 b operates with occludingsolenoid 46. Valves 40 and 42 operate to occlude or not occlude lines 16and 26 downstream of pump 20 a, respectively. Valves 80, 82, 84 and 86operate to occlude or not occlude line 16, line 26, line 88 a and line88 b, respectively.

The valving and line swapping arrangement of FIGS. 9 and 10 enablesfresh dialysate to flow selectively through either of the segments oflines 16 and 26 operating with pump 20 a. The configuration likewiseenables spent dialysate from control container 30 to be pumpedalternatingly through either segment of lines 16 and 26 operable withpump 20 a.

In FIG. 9, fluid flows from supply 12 (see, e.g., system 10, FIGS. 1 and2), past valve 80, line 16, the segment of line 16 contacting pump 20 a,and past valve 40 to filter 18. Simultaneously, spent dialysate ispumped from control container 30 through line 26, past valve 82, throughthe segment of line 26 contacting pump 20 a, and past valve 42 to drainbag 14 or house drain 24.

In FIG. 10, the valve states are reversed such that pump 20 b pumpsfresh dialysate from supply 12, through line swapping flow path 88 b,past valve 86, through the segment of line 26 in contact with line 20 b,through line swapping flow path 48 a, past valve 44, and back into line16 to filter 18. Simultaneously, pump 20 b pumps spent dialysate fromcontrol bag 30, through line swapping flow path 88 a, past valve 84,through the segment of line 16 in contact with pump 20 b, through lineswapping flow path 48 b, past valve 46 and back into line 26 to drainbag 14 or house drain 24.

The valves of FIGS. 9 and 10 are switched so that the flow of freshdialysate to filter 18 matches or at least substantially matches theflow of spent dialysate from control bag 30 to one of the drains. Thepaths may be switched so each different fluid is pumped half the timethrough each segment of lines 16 and 26 operating with pump 20 a.Alternatively, the system of FIGS. 9 and 10 operates with a flowdifferential detection method such that the valves are maintained in onestate until it is determined that a switch needs to be made, after whichthe valves switch until the flow differential is compensated or anotherswitch needs to be made, and so on.

Referring now to FIG. 11, another apparatus and method of compensatingfor differences of dialysate flow through segments 16 and 26 operatingwith pump 20 a is illustrated by system 120. Here, line 26 is removedfrom pump 20 a and is instead made to operate with a third pump 20 c,which receives a pumping speed signal 58 c from control device 100.Bypass line 70 and valves 36, 38 and 40 are provided as described abovein connection with system 110 of FIG. 4. FIG. 11 shows a normal therapyvalve state with valves 38 and 48 open and valve 36 closed, allowingdialysate to flow to and from filter 18.

In a second valve state (not shown), system 120 closes valves 38 and 40,opens valve 36 and uses bypass line 70 to determine any differentialbetween the dialysate flow pumped by pumps 20 a and 20 c through lines16 and 26, respectively. Once any error is determined, the valves areswitched back to the therapy valve state, and control device 100 setsthe speed of pumps 20 a to 20 c accordingly to match the flow of freshand spent dialysate fluid through lines 16 and 26 during therapy. Duringtherapy, control device 100 adjusts pump 20 b to remove UF, if at all,from the patient according to a predetermined rate or UF profile.Control device 100 may be configured to intermittently return to thesecond calibration state intermittently or as needed to redetermine anyerror in flow between pumps 20 a and 20 c.

Referring now to FIGS. 12 to 15, a system including another apparatusand method for compensating between the differences in flow the dualtubing segments operating with pump 20 a is illustrated by system 130.System 130 includes many of the components already described herein,such as, supply 12, drain 14, 24, lines 16 and 22, filter 18, pumps 20 aand 20 b, weighing device 50, etc. For ease of illustration, controldevice 100 is not shown, nor are the signal lines leading to controldevice 100 from weighing device 50, the output signal lines to pumps 20a and 20 b, or the output signal lines to the valves shown in FIGS. 12to 15. System 130 includes all such structures and can include pressuretransducer(s), pressure regulator(s) and/or relief valve(s) in one ormore suitable places as necessary.

One primary difference in system 130 is that a different controlcontainer 132 is employed. Here, control container 132 is divided intofresh and spent dialysate portions 134 and 136. That is, fresh dialysateis pumped into and out of fresh portion 134 of container 132, whilespent dialysate is pumped into and out of spent portion 136 of container132. One advantage of system 130 is that control bag 132 precludesmixing of spent and fresh dialysate (which is more important when supply12 is bagged, sterile dialysate or replacement fluid versus dialysatemade online).

In system 130, pump 20 a pumps fresh dialysate from supply 12 throughline 16 to the filter or diffusion membrane 18 as before. Here, however,pump 20 a is also configured to pump either fresh dialysate through aloop 126 to the inlet of fresh portion 134 of container 132 or spentdialysate from the outlet of spent portion 136 of container 132 todrain. Loop 126 is accordingly connected fluidly to the inlet of freshportion 134 and the outlet of spent portion 136 of container 132.

System 130 includes a number of additional flow paths. A fresh bypasssupply line 138 is connected fluidly to line 16 (between supply 12 andpump 20 a) and loop 126 (upstream of pump 20 a). A fresh bypass returnline 128 is connected fluidly to line 16 (between supply 12 and pump 20a) and to the outlet of fresh portion 134 of control container 132. Aspent bypass supply line 142 is connected fluidly to drain line 22(downstream of pump 20 b) and to the inlet of spent portion 136 ofcontrol bag 132. A bypass line 140 is also connected between loop 126(downstream of pump 20 a) and drain line 22 (downstream of pump 20 b).

System 130 also includes a number of additional valves. A valve 144 iscoupled operably to fresh supply line 16 upstream of pump 20 a. A valve146 is coupled operably to loop 126 prior to the inlet of fresh portion134 of bag 132. A valve 148 is coupled operably to fresh dialysatereturn line 128. A valve 150 is coupled operably to bypass line 140. Avalve 152 is coupled operably to spent bypass supply line 142. A valve154 is coupled operably to fresh bypass supply line 138. A valve 156 iscoupled operably to dialysate line 22 downstream of pump 20 b. A valve158 is coupled operably to loop 126 upstream of pump 20 a.

FIGS. 12 and 13 show system 130 in a first valve state. Here, loop 126of double segment pump 20 a is used to pump fresh dialysate into freshchamber 134 of control container 132. For purposes of illustration,sections of the fluid loop that are not used in the valve state of FIG.12 are removed in FIG. 13. In FIGS. 12 and 13, valves 146, 148, 154 and156 are opened, while all other valves are closed. As seen most readilyin FIG. 13, pump 20 a pumps fresh fluid from supply 12, through line138, past valve 154, through the portion of loop 126 shown in FIG. 13,through the inner tubing segment operating with pump 20 a, past valve146 and into fresh portion 134 of control bag 132. From control bag 132,pump 20 a pumps fresh dialysate past valve 148, through fresh bypassreturn line 128, through the outer tubing segment operating with pump 20a, to the inlet of filter or diffusion membrane 18. At the same time,pump 20 b pumps spent dialysate from filter or diffusion membrane 18,past valve 156, through line 22, to drain bag 14 or house drain 24.

FIGS. 14 and 15 illustrate system 130 in a second valve state. Here,loop 126 operating as the inner dual tube contacting pump 20 a is usedalternatively to pump used dialysate out of spent portion 136 of controlbag 132 to drain. For purposes of illustration, FIG. 15 has removed thesections of the fluid loop that are not used in the second valve state.As seen best in FIG. 15, valves 144, 150, 152 and 158 are opened, whileall other valves are closed. Pump 20 a pumps fresh dialysate from supplybag 12, past valve 144, through the outer tubing segment operating withpump 20 a, and through fresh supply line 16 to the inlet of filter 18.Simultaneously, pump 20 a pumps fluid from the spent dialysate portion136 of container 132, through line 126, past valve 158, through theinner tubing segment operating with pump 20 a, into bypass line 140,past valve 150 and into drain bag 14 or house drain 24. Pump 20 b pumpsspent dialysate from filter 18, through line 22, through bypass line142, past valve 152, and into spent dialysate portion 136 of bag 132.

The first valve state of FIGS. 12 and 13 enables blood clearance tooccur during HD for example. The first valve state of FIGS. 12 and 13also performs a calibration function because the weight of fluid incontainer 132 should remain constant theoretically regardless of thespeed of pump 20 a. This is because pump 20 a pumps dialysate to andfrom fresh compartment 134 of container 132 at the same ratetheoretically, while the weight of spent dialysate in compartment 136remains unchanged. If the weight of dialysate increases in container132, then pump 20 a is pumping more fluid through line 126 than line128/16. If the weight of dialysate decreases in container 132, then pump20 a is pumping more fluid through line 128/16 than line 126. Thedifference can be accounted for by adjusting the speed of pump 20 baccordingly as described above.

Unless the system is to be run open loop, ultrafiltration should notoccur during the first valve state of FIGS. 12 and 13 because there isno way for weighing device 50 to measure any differential weight gainbetween the rate of fluid entering or exiting filter 18. Accordingly,the first valve state may be used sparingly, only at the beginning orend of therapy, during a calibration mode, or at any time of a UFprofile specifying a zero UF rate. The volume of spent portion 136 maytherefore be correspondingly bigger than that of fresh portion 134because in the second state of FIGS. 14 and 15, no fresh dialysate ispumped from or to fresh portion 134 of container 132.

The second valve state of FIGS. 14 and 15 enables blood clearance andultrafiltration to occur during HD for example, taking into account thecalibration information from the first valve state. In the second valvestate, pump 20 a removes spent dialysate from spent portion 136 ofcontainer 132 at the same rate theoretically that it pumps fluid intofilter 18. Pump 20 b pumps spent dialysate from filter 18 to spentportion 136 of container 132.

If the flow through segments of pump 20 a is matched and the weight ofdialysate increases in container 132, then pump 20 b is removing aknowable amount of spent dialysate from the patient at a knowable rate.If the weight of dialysate decreases in container 132, then pump 20 a isadding a knowable amount of fresh dialysate to the patient at a knowablerate. The rate at which fluid is accumulated in spent portion 136 ofcontainer 132 can correspond to a preset or variable UF rate. The secondvalve state of system 130 operates much the same as system 10 of FIGS. 1and 2.

Referring now to FIGS. 16 to 19, yet another system including anotherapparatus and method for compensating between the differences in flowthrough the dual tubing segments operating with pump 20 a is illustratedby system 160. System 160 includes many of the components alreadydescribed herein, such as, supply 12, drain 14, 24, lines 16 and 22,filter 18, pumps 20 a to 20 c, weighing device 50, etc. For ease ofillustration, control device 100 is again not shown, nor are the signallines leading to control device 100 from weighing device 50, the outputsignal lines to pumps 20 a to 20 c, or the output signal lines to thevalves shown in FIGS. 16 to 19. System 160 includes all such structuresand can include pressure transducer(s), pressure regulator(s) and/orrelief valve(s) in one or more suitable places as necessary.

One primary difference in system 160 is that the dual portion controlcontainer 132 discussed above in connection with system 130 is employed.Here again, control container 132 is divided into fresh and spentdialysate portions 134 and 136. The primary difference between system160 and system 130 is that pump 20 a is dedicated to driving freshdialysate from supply 12 to filter 18. Third pump 20 c is added tooperate with loop 126.

In system 160, pump 20 c is configured to pump either fresh dialysatethrough loop 126 to the inlet of fresh portion 134 of container 132 orspent dialysate from the outlet of spent portion 136 of container 132 todrain 14, 24. Loop 126 as illustrated is connected fluidly to the inletof fresh portion 134 and the outlet of spent portion 136 of container132.

System 160 includes the additional flow paths of system 130. Namely,fresh bypass supply line 138 is connected fluidly to line 16 (betweensupply 12 and pump 20 a) and loop 126 (upstream of pump 20 c). Freshbypass return line 128 is connected fluidly to line 16 (between supply12 and pump 20 a) and to the outlet of fresh portion 134 of controlcontainer 132. Spent bypass supply line 142 is connected fluidly todrain line 22 (downstream of pump 20 b) and to the inlet of spentportion 146 of control bag 132. Bypass line 140 is also connectedbetween loop 126 (downstream of pump 20 c) and drain line 22 (downstreamof pump 20 b).

System 160 also includes the additional valves of system 130. Valve 144is coupled operably to fresh supply line 16 upstream of pump 20 a. Valve146 is coupled operably to loop 126 prior to the inlet of fresh portion134 of bag 132. Valve 148 is coupled operably to fresh dialysate returnline 128. Valve 150 is coupled operably to bypass line 140. Valve 152 iscoupled operably to spent bypass supply line 142. Valve 154 is coupledoperably to fresh bypass supply line 138. Valve 156 is coupled operablyto dialysate line 22 downstream of pump 20 b. Valve 158 is coupledoperably to loop 126 upstream of pump 20 a.

FIGS. 16 and 17 show system 160 in a first valve state. Here, a portionof loop 126 is used with pump 20 c to pump fresh dialysate into freshchamber 134 of control container 132. For purposes of illustration,sections of the fluid loop that are not used in the valve state of FIG.12 are removed in FIG. 13. In the first valve state of FIGS. 16 and 17,valves 146, 148, 154 and 156 are opened, while all other valves areclosed. As seen most readily in FIG. 17, pump 20 c pumps fresh fluidfrom supply 12, through line 138, past valve 154, through the portion ofloop 126 shown in FIG. 17, past valve 146 and into fresh portion 134 ofcontrol bag 132. Here, Pump 20 a pumps fresh fluid from fresh portion134, through line 128, past valve 148, through line 16, to filter 18. Atthe same time, pump 20 b pumps spent dialysate from filter or diffusionmembrane 18, past valve 156, through line 22, to drain bag 14 or housedrain 24.

FIGS. 18 and 19 illustrate system 160 in a second valve state. Here,loop 126 is used with 20 c to pump used dialysate out of spent portion136 of control bag 132. For purposes of illustration, FIG. 19 hasremoved the sections of the fluid loop that are not used in the secondvalve state. As seen best in FIG. 19, valves 144, 150, 152 and 158 areopened, while all other valves are closed. Pump 20 a pumps freshdialysate from supply bag 12, past valve 144, through fresh supply line16, to the inlet of filter 18. Simultaneously, pump 20 c pumps fluidfrom the spent dialysate portion 136, through line 126, past valve 158,through bypass line 140, past valve 150 and into drain bag 14 or housedrain 24. Pump 20 b pumps spent dialysate from filter 18, through line22, through bypass line 142, past valve 152, and into spent dialysateportion 136 of bag 132.

In an open-loop arrangement, control device 100 in the first valve statecan set pumps 20 a to 20 c to match the flow of fresh and spentdialysate fluid as best as possible during therapy. During therapy,control device 100 adjusts pump 20 b to remove fluid from the patientaccording to a predetermined rate or UF profile. UF control can beaccomplished by calculating theoretical flowrates for pumps 20 b and 20a/20 c and subtracting theoretical flowrate 20 a/20 c from theoreticalflowrate 20 b.

In a closed loop arrangement, in the first valve state of FIGS. 16 and17, the speed of pump 20 b is set to match the speed of pump 20 c. Toperform ultrafiltration, pump 20 b (and thus pump 20 c) is set at ahigher speed than pump 20 a to remove fluid from the patient accordingto a predetermined rate or UF profile. The difference in fluid pumpedbetween pumps 20 b and 20 a is the same as the difference in fluidpumped between pumps 20 c and 20 a. The difference in fluid pumpedbetween pumps 20 c and 20 a corresponds to a net gain in weight in freshportion 134 of container 132, which is measured by weighing device 50.That net gain in weight corresponds to the amount of ultrafiltrateremoved during the first valve state. The rate at which fluid isaccumulated in fresh portion 134 of container 132 corresponds to thepreset or variable UF rate. Any of the above-described calibration orduring treatment embodiments for detecting and/or correcting fordifferences in flow produced by pump 20 b versus pump 20 c may beincorporated into system 130.

In the second valve state of FIGS. 18 and 19, the speed of pump 20 a isset to match the speed of pump 20 c. To perform ultrafiltration, pump 20b is set at a higher speed than pump 20 a (and thus pump 20 c) to removefluid from the patient according to a predetermined rate or UF profile.The difference in fluid pumped between pumps 20 b and 20 a is the sameas the difference in fluid pumped between pumps 20 b and 20 c. Thedifference in fluid pumped between pumps 20 b and 20 c results in a netgain in weight in spent portion 136 of container 132, which is measuredby weighing device 50. That net gain in weight corresponds to the amountof ultrafiltrate removed during the second valve state. The rate atwhich fluid is accumulated in spent portion 136 of container 132corresponds to the preset or variable UF rate. Any of theabove-described calibration or during treatment embodiments fordetecting and/or correcting for differences in flow produced by pump 20a versus pump 20 c may be incorporated into system 130.

Referring now to FIGS. 20 to 22, three different embodiments for theweighing device/control bag configuration are illustrated. As used inany of the embodiments herein, weighing device 50 is used collectivelyto mean weighing device 50 a in FIG. 20 and weighing device 50 b inFIGS. 21 and 22. As has been described herein, weighing device 50 sendsa signal 52 to control device 100 in each of the embodiments.

In FIG. 20, weighing device 50 a includes a hook or other type ofattachment member 162 from which control container 30 or 132 is hung. Tothat end, control container 30 or 132 can include a perforated tab orother type of attachment device configured and arranged to loop over orhook onto hook 162. In an embodiment, such perforated tab or attachmentdevice is placed on control container 30 or 132 such that it tends tolet container 30 or 132 hang evenly or in a centered positioned. Controlcontainer 30 or 132 in any of the embodiments described herein is aflexible bag or pouch sized to receive the initial amount of fluid plusthe amount of ultrafiltrate produced during therapy. If a normal amountof ultrafiltrate is four liters, for example, then control container orcontrol bag 30 or 132 can be sized to hold five or six liters of fluid,for example.

In FIG. 21, control bag 30 or 132 rests on a platform 164 of weighingdevice 50 b. Here, control container 30, 132 is structurally rigidenough to support itself and the weight of dialysate collected withinthe container. In any case, container 30 or 132 can be made of a plasticor polymeric material, such as a clear or translucent material.

Referring now to FIG. 22, in an another embodiment a bin 166 is placedonto, attached to or formed integrally with platform 164. Controlcontainer 30 or 132 sits within and is supported by bin 166. Controlcontainer 30 or 132 therefore does not need the structural integrity ofcontrol container 30 or 132 of FIG. 21 and can instead be made of aflexible material that can deform within bin 166.

Referring now to FIGS. 23 and 24, in an embodiment, pressure regulators72 a/72 b and/or pressure transducers 56 a/56 b are placed at the inletof the dual segment or single segment pumping peristaltic pumps 20 a to20 c to help ensure that different peristaltic pumps pump the same flow,at equal speeds, when desired. Such regulators 72 a/72 b and transducers56 a/56 b also help to ensure that the single pump 20 a operating dualpump segments of tubes 16 and 26 pumps the same flow at equal speeds.The pressure regulators 72 a/72 b and/or transducers 56 a/56 b arealternatively placed in any combination either upstream or downstream ofany of the peristaltic pumps 20 a to 20 c in any of the embodimentsdescribed herein.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A kidney failure treatmentsystem comprising: a dialysate supply; a weighing device; a controlcontainer coupled operably to the weighing device; a diffusion membrane;a drain; first and second pumps; a first fluid conduit coupled fluidlyto the dialysate supply and the diffusion membrane, the first fluidconduit coupled operably to the first pump; a second fluid conduitcoupled fluidly to the control container and the drain, the second fluidconduit coupled operably to the first pump; and a third fluid conduitcoupled fluidly to the diffusion membrane and the control container, thethird fluid conduit coupled operably to the second pump.
 2. The kidneyfailure treatment system of claim 1, wherein the dialysate supplyincludes at least one of: a container of fresh dialysate and an onlinedialysate generation system.
 3. The kidney failure treatment system ofclaim 1, wherein the diffusion membrane is selected form the groupconsisting of: a dialyzer, a hemofilter and a patient's peritoneum. 4.The kidney failure treatment system of claim 1, wherein the drain is ofa type selected from the group consisting of: a drain container and ahouse drain.
 5. The kidney failure treatment system of claim 1, whereinat least one of the first and second pumps is of a type selected fromthe group consisting of: a peristaltic pump and a membrane pump.
 6. Thekidney failure treatment system of claim 1, wherein at least one of thefirst, second and third conduits includes tubing.
 7. The kidney failuretreatment system of claim 1, which includes a logic implementor coupledoperably to the weighting device, the logic implementor configured tomaintain a desired weight of fluid in the control container.
 8. Thekidney failure treatment system of claim 7, wherein the logicimplementor is configured such that the desired weight of fluid stays atleast substantially constant over time or increases over time.
 9. Thekidney failure treatment system of claim 7, wherein the logicimplementor includes at least one component selected from the groupconsisting of: a processor, a random access memory, a read only memoryand an application specific integrated circuit.
 10. The kidney failuretreatment system of claim 1, wherein the first pump, first conduit andsecond conduit are configured and arranged such that the first pumppumps fluid at an at least substantially same rate through the first andsecond fluid conduits.
 11. The kidney failure treatment system of claim10, wherein the first pump is a peristaltic pump, the first and secondconduits are first and second tubes, and wherein the first and secondtubes are placed collectively around a head of the peristaltic pump. 12.The kidney failure treatment system of claim 1, which includes a flowequalization apparatus coupled fluidly to the first and second conduitsand operably with the first pump, the flow equalization apparatusconfigured to: (i) determine and/or (ii) compensate for unequal flowcaused by the first pump through the first and second conduits.
 13. Thekidney failure treatment system of claim 12, wherein the flowequalization apparatus is of a type selected from the group consistingof: (i) a bypass conduit coupled fluidly to the first and thirdconduits, the bypass conduit enabling a difference of flow through thefirst and second conduits to be sensed; (ii) first and secondloop-closing conduits in fluid communication with the first and secondconduits, respectively, forming closed loops around the first pump,respectively, and first and second valves coupled operably with thefirst and second closed loops, respectively, enabling dialysate to flowselectively through the first and second closed loops; (iii) a pluralityof valved conduits connected fluidly to the first and second conduitsupstream and downstream of the first pump, enabling dialysate from thedialysate supply and the control container to be pumped selectivelythrough the first and second conduits; and (iv) wherein the controlcontainer is divided into fresh dialysate and spent dialysate portions,the first conduit placed in fluid communication with an inlet of thefresh dialysate portion, the second conduit placed in fluidcommunication with the inlet of the fresh dialysate portion and anoutlet of the spent dialysate portion, and the third conduit placed influid communications with an inlet of the spent dialysate portion. 14.The kidney failure treatment system of claim 1, which includes at leastone valve coupled operably to at least one of the first, second andthird conduits.
 15. The kidney failure treatment system of claim 1,which includes a fluid heater configured and arranged to heat dialysateresiding at or flowing from the dialysate supply.
 16. The kidney failuretreatment system of claim 1, wherein the supply bag is divided intofresh and spent dialysate chambers.
 17. The kidney failure treatmentsystem of claim 16, wherein at least one of the conduits is placed influid communication with the fresh dialysate chamber and at least one ofthe other conduits is placed in fluid communication with the spentdialysate chamber.
 18. The kidney failure treatment system of claim 1,which includes at least one pressure transducer and/or relief valvecoupled operably to at least one of the first, second and thirdconduits.
 19. The kidney failure treatment system of claim 1, whereinthe weighing device is configured such that: (i) the control containerhangs from the weighing device; (ii) the control container resides onthe weighing device; or (iii) the control container resides inside abin, the bin supported by the weighing device.
 20. A kidney failuretreatment system comprising: a dialysate supply; a weighing device; acontrol container coupled operably to the weighing device, the controlcontainer divided into fresh dialysate and spent dialysate portions; alogic implementor coupled operably to the weighing device, the logicimplementor configured to maintain a desired weight of fluid in thecontrol container; a diffusion membrane; a drain; first and secondpumps; a first fluid conduit coupled fluidly to the dialysate supply andthe diffusion membrane, the first fluid conduit coupled operably to thefirst pump; a second fluid conduit coupled fluidly to the diffusionmembrane and the drain, the second fluid conduit coupled operably to thesecond pump; and a third fluid conduit coupled fluidly to the fresh, andspent portions of the control container, the third fluid conduit coupledoperably to the first pump.
 21. The kidney failure treatment system ofclaim 20, wherein the third fluid conduit is coupled fluidly to an inletof the fresh portion of the control container, and which includes afourth conduit coupled fluidly to an outlet of the fresh portion. 22.The kidney failure treatment system of claim 21, wherein the fourthfluid conduit is coupled fluidly to the first conduit.
 23. The kidneyfailure treatment system of claim 20, wherein the third fluid conduit iscoupled fluidly to an outlet of the spent portion of the controlcontainer, and which includes a fourth fluid conduit coupled fluidly toan inlet of the spent portion.
 24. The kidney failure treatment systemof claim 23, wherein the fourth fluid conduit is coupled fluidly to thesecond conduit.
 25. The kidney failure treatment system of claim 20,wherein at least one of the first, second and third fluid conduits iscoupled mechanically to its respective first or second pump.
 26. Thekidney failure treatment system of claim 20, wherein the third fluidconduit is coupled fluidly to at least one of the dialysate supply andthe drain.
 27. The kidney system of claim 20, which includes afresh-portion-valve-state in which fresh dialysate can be pumped to andfrom the fresh portion of the control container.
 28. The kidney failuretreatment system of claim 27, wherein at least one of aspent-portion-inlet and spent-portion-outlet valve is closed in thefresh-portion-valve-state.
 29. The kidney failure treatment system ofclaim 27, wherein the first pump pumps fresh dialysate to and from thefresh portion in the fresh-portion-valve-state.
 30. The kidney failuretreatment system of claim 27, which is configured such that at least oneof: (i) spent dialysate can be pumped from the diffusion membrane to thedrain; and (ii) fresh dialysate can be pumped to the diffusion membranein the fresh-portion-valve-state.
 31. The kidney failure treatmentsystem of claim 27, which includes a spent-portion-valve-state in whichspent dialysate can be pumped to and from the spent portion of thecontrol container.
 32. The kidney failure treatment system of claim 20,wherein the second pump is configured to pump spent dialysate to thedrain.
 33. The kidney failure treatment system of claim 20, whichincludes a spent-portion-valve-state in which spent dialysate can bepumped to and from the spent portion of the control container.
 34. Thekidney failure treatment system of claim 33, wherein at least one of afresh-portion-inlet and fresh-portion-outlet valve is closed in thespent-portion-valve-state.
 35. The kidney failure treatment system ofclaim 33, wherein at least one of: (i) the first pump is configured topump spent dialysate from the spent portion of the control containers;and (ii) the second pump is configured to pump fresh dialysate to thespent portion in the spent-portion-valve-state.
 36. The kidney failuretreatment system of claim 33, which is configured such that at least oneof: (i) fresh dialysate can be pumped to the diffusion membrane; and(ii) spent dialysate can be pumped to the drain in thespent-portion-valve-state.
 37. The kidney failure treatment system ofclaim 33, wherein the first pump is configured to pump: (i) spentdialysate from the spent portion to drain; and (ii) fresh dialysate fromthe supply to the diffusion membrane in the spent-portion-valve state.38. The kidney failure treatment system of claim 20, wherein thedialysate supply includes at least one of: a container of freshdialysate and an online dialysate generator system.
 39. The kidneyfailure treatment system of claim 20, wherein the diffusion membrane isselected form the group consisting of: a dialyzer, a hemofilter and apatient's peritoneum.